The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).
The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.
Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.
It is claimed to be the only dengue vaccine that has been approved in the country for use in people without the need for pre-vaccination testing and regardless of previous exposure.
The company stated that the vaccine needs to be used as per official recommendations.
Takeda Brazil president José Manuel Caamaño said: “Brazil has a high prevalence of dengue, and the country needs effective and safe vaccine options to help manage the significant burden dengue places on its health care systems and its communities.
“We are proud to make our vaccine available to the Brazilian government and health care providers with the hope that it may become an important tool to help combat dengue as part of an integrated dengue management programme along with vector control.
“Based on our clinical trial results, we are hopeful that Qdenga could have a positive impact on the incidence of symptomatic dengue in Brazil, including dengue cases that require hospitalisation.”
The regulatory approval is based on the data obtained across 19 Phase I, II and III clinical trials, conducted on more than 28,000 children and adults.
Additionally, four and a half years of follow-up data from the Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) supported the approval.
The company continues to advance regulatory filings in other dengue-endemic countries in Asia and Latin America.
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